Active Ingredient (In Each Capsule)
Cetirizine HCl 10 mg
Allergy Relief Capsule, Liquid Filled
FDA Label NDC 56062-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc for the product Allergy Relief (NDC 56062-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Do Not Use
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask A Doctor Before Use If You Have
liver or kidney disease. Your doctor should determine if you need a different dose.
Ask A Doctor Or Pharmacist Before Use If You Are
taking tranquilizers or sedatives.
When Using This Product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
adults and children 6 years and over | one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
adults 65 years and over | ask a doctor |
children under 6 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
- store between 68-77°F (20-25°C)
- avoid high humidity and excessive heat above 104°F (40°C)
- protect from light
- do not use if printed foil under cap is broken or missing
Inactive Ingredients
butylated hydroxytoluene, gelatin, glycerin, mannitol, may contain pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol
Package/Label Principal Display Panel
ORIGINAL PRESCRIPTION STRENGTH
allergy relief
CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg
ANTIHISTAMINE
24-hour relief of:
• Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose
INDOOR & OUTDOOR ALLERGIES
ACTUAL SIZE
25 LIQUID GELS**
**LIQUID-FILLED CAPSULES
Compare to Zyrtec® Liquid Gels active ingredient
98n-63-allergy-relief (Image 01)
* Please review the disclaimer below.
